ICD Guidelines Ignored to Patients' Peril

Posted on behalf of Stewart Bell, PLLC on Jan 11, 2011 in Wrongful Death

At dinner tables throughout Charleston, families are debating healthcare reform. It's likely the discussion will turn to quality of care at some point, and evidence-based medicine is a key part of quality improvement. From evidence-based medicine emerge best practices, or care guidelines. Some practitioners and members of the public object to guidelines, arguing that each patient is unique and cannot fall into a formula approach. However, a study published in the Journal of the American Medical Association last week showed that in the case of one medical device, the heart implantable cardioverter-defibrillator (ICD), not adhering to the guidelines significantly increases the risk to the patient.

ICDs are appropriate for patients who have advanced heart failure. When the patient's heart beats irregularly, the device shocks it back to normal rhythm. Researchers have found that implanting an ICD in other patients -- people who have recently had bypass surgery or suffered a heart attack -- is not beneficial. Based on this research, the guidelines do not recommend implanting a defibrillator in a patient who has a limited life expectancy or a patient who has a recent heart failure diagnosis.

In the JAMA study, the researchers found that surgeons continue to implant ICDs in patients who fall outside of the guidelines. Reviewing data from about 112,000 patients who received implants between 2006 and 2009, the researchers compared outcomes for patients falling within and patients falling outside of the guidelines. The results showed that patients who fell within the guidelines were less likely to suffer complications and had a reduced risk of dying in hospital. Of the 112,000 patients in the study, 22 percent fell solidly into a category of patient not recommended for an implant.

An author of the study believes that those surgeries were the result of a lack of knowledge of the guidelines; she admitted, as well, that some surgeons may not agree with the guidelines. Other health care professionals say the results are disturbing. Not only are patients being harmed by unnecessary surgery, but the surgeries are expensive. With ICDs, the costs of unnecessary medical care are measured in human and fiscal terms.

Resource: LawyersandSettlements.com "One in Five Defibrillator Implants (ICDs) May Be Outside the Guidelines" 01/blog/11

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